EUCTR2011-002140-27-Outside-EU/EEA进行中（未招募）不适用
A phase III, open study in children previously enrolled in study 10PN-PD-DIT-037 (111188) to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when administered as a booster dose at either 9-18 or 15-18 months of age in primed children or when administered as a catch-up vaccination (2+1 schedule) in unprimed children during the second year of life. - 10PN-PD-DIT-062 BST:037
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
- •For primed subjects:
- •-Completion of the full vaccination course in study 10PN-PD-DIT-037 (111188).
- •-9-18 months at the time of randomization.
- •-9-18 months of age at the time of booster vaccination for the Pn-Pn9 group.
- •-15-18 months of age at the time of booster vaccination for the Pn-Pn15 group.
- •For unprimed subjects:
- •-Enrolled in study 10PN-PD-DIT-037 (111188).
- •-12-18 months of age at the time of first vaccination in the present study.
- •Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 360
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product within 30 days preceding the vaccination, or planned use during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- •Administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-037 (111188).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
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